EMA Reviewing Guide To Support New Genome Editing Technologies, CAR-T Cell Therapies

25 Jul 2017

The European Medicines Agency is updating its five-year old guideline on drugs containing genetically modified cells to factor in rapid scientific developments in relation to gene editing technologies, and the development of promising new cancer immunotherapies, such as CAR-T cells.

CRISPR — EMA Is Reviewing Its Guidance To Keep Pace With New Genome Editing Technologies • Source: Shutterstock

The European Medicines Agency has proposed revising its five-year old guideline on medicinal products containing genetically-modified cells to primarily address the availability of improved genome editing technologies and to incorporate quality, non-clinical and clinical issues specific to chimeric antigen receptor (CAR)-T cells.

The proposed changes are outlined in a concept paper in which the EMA notes that its existing guideline...